CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.— 510(k) K881138
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K881138 for CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO., Substantially Equivalent on 1988-04-21. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code JMG
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
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